Treats schizophrenia As monotherapy or adjunctive therapy with lithium or valproate. NDA 21444, held by Janssen Pharms. Risperidone.
As of Nov 14, 2026, NDA 21444 (Risperdal), held by Janssen Pharms, was first approved by FDA on Apr 2, 2003, with 33 approved supplements and 0 published complete response letters.
RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder Treatment of irritability associated with autistic disorder 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults. 1.2 Bipolar Mania Monotherapy RISPERDAL is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
| Aug 2, 2012 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2007 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2007 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2006 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 4, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2003 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Apr 2, 2003 | Original applicationNew dosage form · Standard review | Approved |
| Risperdal0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Risperidone | DiscontinuedReference drug |
| Risperdal1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Risperidone | DiscontinuedReference drug |
| Risperdal2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Risperidone | DiscontinuedReference drug |
| Risperdal3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Risperidone | DiscontinuedReference drug |
| Risperdal4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Risperidone | DiscontinuedReference drug |
| Jan 22, 2025 | Supplement 60Labeling · Standard review | Approved | |
| Dec 2, 2022 | Supplement 59Labeling · Standard review | Approved | |
| Feb 12, 2021 | Supplement 57Labeling · Standard review | Approved | |
| Feb 5, 2020 | Supplement 58Labeling | Approved | |
| Jan 25, 2019 | Supplement 56Labeling · Standard review | Approved | |
| Jul 27, 2018 | Supplement 54Labeling · Standard review | Approved | |
| Feb 23, 2017 | Supplement 52Labeling | Approved | |
| Mar 1, 2016 | Supplement 51Labeling · Standard review | Approved | |
| Apr 28, 2014 | Supplement 48Labeling · Standard review | Approved | |
| Aug 2, 2012 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Mar 12, 2012 | Supplement 43Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 42Labeling · Standard review | Approved | |
| Sep 24, 2011 | Supplement 35Labeling · Standard review | Approved | |
| Aug 24, 2011 | Supplement 34Labeling · Standard review | Approved | |
| Jun 15, 2011 | Supplement 40Labeling · Standard review | Approved | |
| Dec 1, 2010 | Supplement 39Labeling | Approved | |
| Aug 30, 2010 | Supplement 37Labeling | Approved | |
| Aug 30, 2010 | Supplement 36Labeling | Approved | |
| Aug 30, 2010 | Supplement 33Labeling | Approved | |
| Aug 30, 2010 | Supplement 30Labeling · Standard review | Approved | |
| Jul 19, 2009 | Supplement 31Labeling | Approved | |
| Aug 14, 2008 | Supplement 29Labeling · Standard review | Approved | |
| Aug 22, 2007 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Aug 22, 2007 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Oct 6, 2006 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 2006 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Aug 17, 2005 | Supplement 16Labeling · Standard review | Approved | |
| Dec 23, 2004 | Supplement 12Manufacturing · Standard review | Approved | |
| Dec 4, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2003 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Oct 29, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Sep 10, 2003 | Supplement 4Labeling · Standard review | Approved | |
| Apr 2, 2003 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
